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DNA/RNA Extraction/Purification Kit

by Hangzhou Bigfish Bio-tech Co., Ltd. China EUDAMED

Ref BFMP07R96Model 1T、32T、96T、100T、256T

EMDN W0104080699

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697551436BFMP001NK Basic UDI-DIDate28 Feb 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
DNA/RNA Extraction/Purification Kit
Model / Reference
1T、32T、96T、100T、256T, BFMP07R96
Primary DI / UDI-DI
06975514361029
Basic UDI-DI
697551436BFMP001NK
EMDN Code
W0104080699 Nucleic acid identification (bacteriology) manual / automated - other
Device Class
Class A
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000027212
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Hangzhou Bigfish Bio-tech Co., Ltd.

See all devices from Hangzhou Bigfish Bio-tech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06975514361029|697551436BFMP001NK 61 fields · synced 24 Oct 2026